Ailing FDA May Need Major Restructuring

The Obama administration will inherit a Food and Drug Administration widely seen as struggling to protect Americans from unsafe medication, contaminated food and a flood of questionable imports from China and other countries.

Shaken by a series of alarming failures, the FDA desperately needs an infusion of strong leadership, money, technology and personnel -- and perhaps a major restructuring, say former officials, members of Congress, watchdog groups and various government reports.

"Everywhere you go, you hear the same chorus: The agency's in trouble," said David A. Kessler, who served as FDA commissioner under Presidents George H.W. Bush and Bill Clinton. "There's a general perception the agency is suffering mightily."

With nearly 11,000 employees and an annual budget of more than $2 billion, the FDA is charged with overseeing products that account for one-quarter of consumer spending in the United States, including over-the-counter and prescription medications, heart valves, stents and other medical devices, the blood supply, and food.

But morale within the FDA, along with its credibility outside, has plummeted as the agency has been stretched to keep pace with its responsibilities and riven by accusations of ideological bias, a tilt toward industry rather than consumers, and internal dissension.

"FDA is close to being at a tipping point -- the agency is hanging on by its fingertips in protecting us," said William K. Hubbard, who worked for the agency for 27 years. "If something is not done, they could become a failed institution, and no one wants that. The FDA is not only important to protecting the public health but also to the industries it regulates."

Alarm about the agency began to spike after a series of highly publicized incidents, including the discovery that the painkiller Vioxx caused heart attacks. That has been followed by other safety issues, including questions about the widely used diabetes medication Avandia and several psychiatric drugs.

"I'm afraid we're going to see more horrible things happen if we don't get our act together on this," said David Ross, who was a drug reviewer at the agency for 10 years.

At the same time, there has been increasing alarm about the agency's ability to protect the food supply -- concerns highlighted by recent major outbreaks of E. coli infection in spinach and salmonella in spinach and peppers. That has prompted calls to split the agency in two -- with one dedicated to drugs and the other to food.

"Food safety tends to get short shrift," said Christopher Waldrop of the Consumer Federation of America. "The drug side tends to get much more attention than the food side. Food is equally important and needs to get the attention it deserves."

Both the food and drug parts of the FDA's responsibilities have been hobbled by its inability to adequately monitor goods pouring into the United States from around the world, including food, drugs and raw materials, many say. Such concerns were highlighted by contaminated toothpaste from China; tainted pet food that killed hundreds of dogs and cats; and the fouled blood thinner heparin, which took the lives of at least 81 Americans and caused hundreds of serious illnesses.

"The agency is still stuck at the border," said Carl R. Nielsen, who was in charge of the FDA's import operations for the last six of his 28 years at the agency. "There has to be radical reorganization -- no doubt about that."

Although the FDA has started opening offices overseas to try to better police safety standards at the source, experts say much more needs to be done. For starters, the agency needs to sharply boost inspections abroad, develop strict new regulatory standards, and update and integrate its computer systems, which are woefully antiquated and disjointed, Nielsen and others said.

"It's still largely a paper-driven agency," Nielsen said. "The agency has great information pigeonholed all over the place, but it cannot be applied in real time, which is what you need today."

The FDA has also been one of the many federal agencies where Bush administration critics say ideology has trumped science, citing the long delay in approving the over-the-counter sale of the emergency contraceptive Plan B.

"The agency needs to get back to using science as the basis for its decision-making," said Jane E. Henney, who ran the FDA under Clinton from 1998 to 2001.

Questions have also been raised about the agency's handling of suspected toxins such as bisphenol A in baby bottles and other products. And internal dissension has erupted publicly from the usually hermetically sealed agency. Last week, the House Energy and Commerce Committee released a letter from FDA scientists complaining about "serious misconduct" by top managers who oversee medical devices.

The turmoil comes as the FDA is facing a host of new demands, including the next wave of drugs and other products resulting from breakthroughs in genetics, nanotechnology and bioengineered foods, among others. And Congress may give the FDA the power to regulate tobacco for the first time.

"This would be a totally new regulatory responsibility that the FDA doesn't have expertise in," said Mark B. McClellan, who led the agency in President George W. Bush's first term.

While the agency has received some additional money and personnel to help implement new drug safety powers, many say it is overdue for a doubling of its budget.

"There's broad bipartisan recognition from consumer groups and from industry that the FDA needs more resources," McClellan said. "The most important thing is overall effective leadership that leads in a way that establishes public trust."

Many hope the new administration will quickly name a new FDA commissioner -- a post that has frequently been left in the hands of acting commissioners for long periods. An acting commissioner ran the agency for more than half of the past eight years.

"The FDA can't be left to drift," said Hubbard, the former official. "There's a lack of leadership when a caretaker is in charge, and the FDA can't afford that."